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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Image Processing, Radiological
510(k) Number K192890
Device Name SentEP
Applicant
SentiAR, Inc
212 Kingshighway Blvd., Suite 115
Mailbox 28
St. Louis,  MO  63108
Applicant Contact Berk Tas
Correspondent
SentiAR, Inc
212 Kingshighway Blvd., Suite 115
Mailbox 28
St. Louis,  MO  63108
Correspondent Contact Berk Tas
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/10/2019
Decision Date 09/18/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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